Premarket Approval (PMA)

Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.

• Device: ProACT™ Adjustable Continence Therapy for Men
• Generic Name: Device, incontinence, mechanical/hydraulic
• Regulation Number: 876.5280
• Applicant: Uromedica, Inc.; 1840 Berkshire Ln. N.; Plymouth, MN 55441
• PMA Number: P130018
• Supplement Number: S005
• Date Received: 12/30/2025
• Decision Date: 01/28/2026
• Product Code: EZY
• Advisory Committee: Gastroenterology/Urology
• Supplement Type: Special (Immediate Track)
• Supplement Reason: Labeling Change - Indications/instructions/shelf life/tradename
• Expedited Review Granted?: No
• Combination Product: No
• Predetermined Change Control Plan Authorized: No

Approval Order Statement  
for the addition of four potential adverse events and updates to the MRI Information section of the instructions for use